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- Atar, D., et al.
(författare)
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Effect of intravenous FX06 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction results of the F.I.R.E. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury) trial
- 2009
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Ingår i: Journal of the American College of Cardiology. - 1558-3597. ; 53:8, s. 720-9
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: The purpose of this study was to investigate whether FX06 would limit infarct size when given as an adjunct to percutaneous coronary intervention. BACKGROUND: FX06, a naturally occurring peptide derived from human fibrin, has been shown to reduce myocardial infarct size in animal models by mitigating reperfusion injury. METHODS: In all, 234 patients presenting with acute ST-segment elevation myocardial infarction were randomized in 26 centers. FX06 or matching placebo was given as intravenous bolus at reperfusion. Infarct size was assessed 5 days after myocardial infarction by late gadolinium enhanced cardiac magnetic resonance imaging. Secondary outcomes included size of necrotic core zone and microvascular obstruction at 5 days, infarct size at 4 months, left ventricular function, troponin I levels, and safety. RESULTS: There were no baseline differences between groups. On day 5, there was no significant difference in total late gadolinium enhanced zone in the FX06 group compared with placebo (reduction by 21%; p = 0.207). The necrotic core zone, however, was significantly reduced by 58% (median 1.77 g [interquartile range 0.0, 9.09 g] vs. 4.20 g [interquartile range 0.3, 9.93 g]; p < 0.025). There were no significant differences in troponin I levels (at 48 h, -17% in the FX06 group). After 4 months, there were no longer significant differences in scar size. There were numerically fewer serious cardiac events in the FX06-treated group, and no differences in adverse events. CONCLUSIONS: In this proof-of-concept trial, FX06 reduced the necrotic core zone as one measure of infarct size on magnetic resonance imaging, while total late enhancement was not significantly different between groups. The drug appears safe and well tolerated. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury [F.I.R.E.]; NCT00326976).
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- Mehta, Vishal S., et al.
(författare)
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Machine learning-derived major adverse event prediction of patients undergoing transvenous lead extraction : Using the ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry
- 2022
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Ingår i: Heart Rhythm. - : Elsevier. - 1547-5271 .- 1556-3871. ; 19:6, s. 885-893
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND Transvenous lead extraction (TLE) remains a high-risk procedure. OBJECTIVE The purpose of this study was to develop a machine learning (ML)-based risk stratification system to predict the risk of major adverse events (MAEs) after TLE. A MAE was defined as procedure-related major complication and procedure-related death. METHODS We designed and evaluated an ML-based risk stratification system trained using the European Lead Extraction ConTRolled (ELECTRa) registry to predict the risk of MAEs in 3555 patients undergoing TLE and tested this on an independent registry of 1171 patients. ML models were developed, including a self-normalizing neural network (SNN), stepwise logistic regression model ("stepwise model"), support vector machines, and random forest model. These were compared with the ELECTRa Registry Outcome Score (EROS) for MAEs. RESULTS There were 53 MAEs (1.7%) in the training cohort and 24 (2.4%) in the test cohort. Thirty-two clinically important features were used to train the models. ML techniques were similar to EROS by balanced accuracy (stepwise model: 0.74 vs EROS: 0.70) and superior by area under the curve (support vector machines: 0.764 vs EROS: 0.677). The SNN provided a finite risk for MAE and accurately identified MAE in 14 of 169 "high (<80%) risk" patients (8.3%) and no MAEs in all 198 "low (,20%) risk" patients (100%). CONCLUSION ML models incrementally improved risk prediction for identifying those at risk of MAEs. The SNN has the additional advantage of providing a personalized finite risk assessment for patients. This may aid patient decision making and allow better preoperative risk assessment and resource allocation.
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- Sidhu, Baldeep S., et al.
(författare)
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Risk stratification of patients undergoing transvenous lead extraction with the ELECTRa Registry Outcome Score (EROS) : an ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry analysis
- 2021
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 23:9, s. 1462-1471
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: Transvenous lead extraction is associated with a significant risk of complications and identifying patients at highest risk pre-procedurally will enable interventions to be planned accordingly. We developed the ELECTRa Registry Outcome Score (EROS) and applied it to the ELECTRa registry to determine if it could appropriately risk-stratify patients.METHODS AND RESULTS: EROS was devised to risk-stratify patients into low risk (EROS 1), intermediate risk (EROS 2), and high risk (EROS 3). This was applied to the ESC EORP European Lead Extraction ConTRolled ELECTRa registry; 57.5% EROS 1, 31.8% EROS 2, and 10.7% EROS 3. Patients with EROS 3 or 2 were significantly more likely to require powered sheaths and a femoral approach to complete procedures. Patients with EROS 3 were more likely to suffer procedure-related major complications including deaths (5.1 vs. 1.3%; P < 0.0001), both intra-procedural (3.5 vs. 0.8%; P = 0.0001) and post-procedural (1.6 vs. 0.5%; P = 0.0192). They were more likely to suffer post-procedural deaths (0.8 vs. 0.2%; P 0.0449), cardiac avulsion or tear (3.8 vs. 0.5%; P < 0.0001), and cardiovascular lesions requiring pericardiocentesis, chest tube, or surgical repair (4.6 vs. 1.0%; P < 0.0001). EROS 3 was associated with procedure-related major complications including deaths [odds ratio (OR) 3.333, 95% confidence interval (CI) 1.879-5.914; P < 0.0001] and all-cause in-hospital major complications including deaths (OR 2.339, 95% CI 1.439-3.803; P = 0.0006).CONCLUSION: EROS successfully identified patients who were at increased risk of significant procedural complications that require urgent surgical intervention.
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